cervical cancer
Conditions
Interventions
Cohort1:cadonilimab 6mg/kg, iv, d1, q2w
disitamab vedotin 2.5mg/kg, iv, d1, q2w
Cohort2:cadonilimab 10mg/kg, iv, d1, q3w
nab-paclitaxel 260mg/m2, iv, d1, q3w (6 cycle)
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in clinical research; Fully understand and be informed of this study, and sign an informed consent form; Willing to follow and capable of completing all testing procedures; 2. If confirmed by histopathology as cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma, if there are small cell carcinoma, neuroendocrine carcinoma, clear cell carcinoma, or sarcoma components, they will not be included in the group; 3. Patients with recurrent or metastatic cervical cancer who have progressed after 1-3 lines of chemotherapy, or those who cannot tolerate the aforementioned chemotherapy regimen; 4. Cohort 1: HER2 protein is expressed in tumor tissue (IHC 1+ and above), while Queue 2: HER2 protein is not expressed in tumor tissue (IHC-); 5. Age 18-75 years old; 6. According to the RECIST 1.1 standard, there should be at least one measurable lesion, that is, based on CT cross-sectional images or MRI, the length and diameter of non lymph node lesions should be >= 10 mm, or the short diameter of lymph node lesions should be >= 15 mm; 7. The Eastern Oncology Collaborative Group (ECOG) in the United States has a physical condition score of 0 to 1; 8. Expected survival time exceeding 3 months; 9. Organ function and hematopoietic function must meet the following requirements: (1) Hemoglobin (HGB) >= 80g/L; (2) White blood cell count (WBC) >= 3 × 10^9/L; (3) Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; (4) Platelet count (PLT) >= 80 × 10^9/L; (5) Total bilirubin (TBIL) = 50mL/min; (8) International standardized ratio (INR) or plasma prothrombin time (PT) <= 1.5 × ULN; 10. Female participants of childbearing age must agree to take effective contraceptive measures within 5 months after signing the informed consent form; 11. The subjects agree and are able to provide archived tumor samples (paraffin blocks or unstained sections that meet the testing requirements specified by our research institute).
Exclusion criteria
Exclusion criteria: 1. Those who have previously used Cadonilimab, Disitamab Vedotin, Albumin Paclitaxel, Elibrin, or Vinorelbine; 2. Those who have received other anti-tumor treatments (including chemotherapy, molecular targeted therapy, radiotherapy, immunotherapy, monoclonal antibody therapy) within 4 weeks before the start of research treatment, or have participated in clinical studies of other unlisted drugs; 3. Known subjects who have previously been allergic to macromolecular protein formulations/monoclonal antibodies, or known to be allergic to any component of the investigational drug; 4. Pregnant or lactating women; 5. Have active autoimmune diseases and have received systemic treatment (such as corticosteroids or immunosuppressive drugs) within the past 2 years, including but not limited to: uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism (asymptomatic hypothyroidism or hypothyroidism caused by radiotherapy and chemotherapy can be included); 6. Those who need to receive systemic corticosteroids (with a dose equivalent to or higher than 10mg/day of prednisone) or other immunosuppressive drugs within 14 days before enrollment or during the study period; 7. Patients with meningeal metastasis or symptomatic central nervous system metastasis; 8. Those who have received live vaccines within 4 weeks before the start of treatment; 9. Those who have received anti-tumor vaccines or received anti-tumor therapy with systemic immune stimulation; 10. Accompanied with serious medical diseases, such as severe infection, uncontrollable diabetes Cardiovascular disease (defined by the New York Heart Association as Grade III or IV heart failure, Grade II or above heart block, myocardial infarction, unstable arrhythmia or angina pectoris within the past 6 months, cerebral infarction within 3 months, etc.) or pulmonary disease (history of interstitial pneumonia, obstructive pulmonary disease, and symptomatic bronchospasm); 11. People with positive hepatitis B B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) and more than 103 copies/ml of hepatitis B B virus deoxyribonucleic acid (HBV DNA), or positive hepatitis C virus antibody; Syphilis positive individuals; 12. Have a history of infection with human immunodeficiency virus, or suffer from other acquired or congenital immunodeficiency diseases; 13. Individuals with a history of active tuberculosis infection within one year prior to enrollment; 14. Those who have developed other malignant tumors within the past 5 years prior to enrollment, excluding any type of previously cured in situ cancer, as well as healed basal cell carcinoma or squamous cell carcinoma of the skin; 15. Previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation; 16. Patients with a history of digestive tract perforation or undergoing major surgical procedures (excluding baseline tumor biopsy) or severe trauma, active ulcers, intestinal perforation, intestinal obstruction, or unhealed fractures within 4 weeks prior to the start of study treatment; 17. Have a history of alcohol, drug or substance abuse within the past year; 18. Individuals with a clear history of neurological or mental disorders, such as epilepsy, dementia, and poor compliance; 19. Other severe, acute, or chronic diseases or laboratory test abnormalities that may increase the risk of participating in research and drug use, or may interfere with the interpretati
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate, DCR;disease progression-free time, PFS;Duration of Response, DOR;Overall Survival, OS;Safety; | — |
Countries
China
Contacts
Public ContactZheng Min
Sun Yat-sen University Cancer Center
Outcome results
None listed